Senior Process Development Engineer, Sterile Drug Product

Amgen; Dublin; On-site; EUR 90,000 - 150,000; Full time

Job summary

Amgen is seeking a Process Development specialist to support NPI, tech transfer, and lifecycle changes for vial and syringe products. The role provides SME guidance on formulation, filling, and characterization for both large and small molecule drug products within the PD organization.

The ideal candidate will contribute to regulatory filings, lead risk assessments, and drive CAPA initiatives while collaborating with manufacturing and other support functions to ensure robust and compliant

Qualifications

• Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience
• Knowledge of cGMPs and other worldwide regulatory requirements
• Problem solving ability and excellent oral and written communications skills

Responsibilities

• Lead new product introductions and lifecycle changes into production lines from a Process Development perspective and then serve as the Process Development SME
• Support regulatory filings during the NPI process including authoring, editing, submission and responding to regulator questions
• Provide solutions for drug product processing issues in sterile filling, formulation, and parenteral device handling
• Develop and transfer drug product processes to commercial sites and support tech transfer
• Develop validation plans and PPQs for syringe filling and other processes
• Lead cross-site teams and assist in deviation resolution and root cause analysis

Skills

cGMP knowledge

Problem solving

Communication skills

Education

Bachelor's degree in Science/Engineering

Master's degree in Science/Engineering

Associate's degree with 10 years' experience

Job description

Amgen is seeking a Process Development specialist to support NPI, tech transfer, and lifecycle changes for vial and syringe products. The role provides SME guidance on formulation, filling, and characterization for both large and small molecule drug products within the PD organization.

The ideal candidate will contribute to regulatory filings, lead risk assessments, and drive CAPA initiatives while collaborating with manufacturing and other support functions to ensure robust and compliant